TACE and Sorafenib Combination Shows Promise for Advanced HCC
The combination of sorafenib and transarterial chemoembolization (TACE) for patients with advanced hepatocellular carcinoma (HCC) seems feasible and promising, researchers reported.
Phase III trials have not shown a clinical benefit of the combined therapy, but there have been signs of promise in other studies, including retrospective cohort studies and recent prospective phase II clinical trials. The authors of the current study conducted a multicenter phase II clinical study to build on these results and further investigate the safety and efficacy of the combination therapy.
The study included 31 systemic chemotherapy–naïve patients with a Child-Pugh class A liver profile and advanced stage HCCs. There were 24 men and 7 women enrolled; patients had a median age of 75 years. Four weeks after the initial TACE, with an allowance of subsequent on-demand conventional chemoembolization, patients began a daily dose of 800 mg sorafenib. The researchers evaluated the rate of protocol treatment completion (defined as sorafenib administration for at least 2 months) as the primary endpoint. Objective response rate, disease control rate, overall survival, progression-free survival, and incidence of adverse events were the secondary endpoints.
Twenty-eight patients completed the protocol treatment with a median of 7.0 months median protocol treatment duration and median of 2 TACE sessions. There was an objective response rate of 77.4%, median overall survival of 17.3 months, and 5.4 months median progression-free survival. Regarding adverse events, self-limiting elevation of aspartate aminotransferase and alanine aminotransferase were the most common grade 3 or 4 adverse events.
“In conclusion, the findings of the present study indicate that combining sorafenib with transarterial chemoembolization is feasible and promising even for advanced stage HCCs. The utility of this combination therapy should be evaluated in future studies with larger clinical trials,” the authors wrote.
Sato Y, Nishiofuku H, Yasumoto T, et al. Multicenter Phase II Clinical Trial of Sorafenib Combined with Transarterial Chemoembolization for Advanced Stage Hepatocellular Carcinomas (Barcelona Clinic Liver Cancer Stage C): STAB Study. J Vasc Interv Radiol. 2018 Jun 19. pii: S1051-0443(18)31049-2. doi: 10.1016/j.jvir.2018.03.020. [Epub ahead of print].